NCT02737241

Brief Summary

HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate Hyperplasia).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

March 27, 2016

Last Update Submit

March 31, 2018

Conditions

Prostatic Hyperplasia

Keywords

ProstateLaserEnucleation

Outcome Measures

Primary Outcomes (3)

  • Operative time (minutes)

    Which is the time from insertion of the resectoscope till the time of catheterization

    one day

  • Operative efficacy (gm/minute)

    Which is the number or grams of the resected prostate tissue weight divided by operative time

    one day

  • Enucleation efficacy (gm/minute)

    Which is the number of grams of the resected prostate tissue divided by enucleation time

    one day

Secondary Outcomes (2)

  • dysuria score

    4 weeks

  • Maximum urine flow rate (ml/sec)

    3 months

Study Arms (2)

LP-HoLEP

ACTIVE COMPARATOR

Low power Holmium laser enucleation of the prostate

Procedure: Low power Holmium laser enucleation of the prostate

HP-HoLEP

ACTIVE COMPARATOR

High power Holmium laser enucleation of the prostate

Procedure: High power Holmium laser enucleation of the prostate

Interventions

Low power Holmium laser enucleation of the prostatePROCEDURE

HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 50W holmium laser energy.

LP-HoLEP
High power Holmium laser enucleation of the prostatePROCEDURE

HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 100W holmium laser energy.

HP-HoLEP

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' age ≥50 years
  • ASA (American society of anesthesiologists) score ≤3.
  • TRUS (transrectal ultrasound) estimated weight ≥40 grams.

You may not qualify if:

  • Patients who have any of the following were excluded:
  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
  • Active urinary tract infection.
  • Presence of bladder cancer (within the last 2 years).
  • Prostate cancer patients.
  • Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
  • Previous prostate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed M Elshal, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 13, 2016

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

February 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)